News & Events

News & Events

2014 Edition and 2015 Edition Program - Updates 10-30-2017

Updates on Enhanced Oversight Rules

As part of the Enhanced Oversight and Accountability Rule published last year, ONC recently provided additional guidance regarding Direct Oversight and Certification Bans. ONC has the authority to suspend or terminate a certification based on the results of a direct review per 45 CFR §170.580 and §170.581

Self-Declaration for Certain Certification Criteria

On September 21, 2017 ONC announced updates to the 2015 Edition ONC Health IT certification program to support efficiency and reduce testing burdens on developers. As a result of this announcement, Health IT developers will now be able to certify to 30 of the 55 2015 Edition criteria through self-declaration as opposed to demonstration or attestation. The test procedures for these 30 criteria, found here, have been designated as attestation/developer self-declaration.

In order to qualify for these criteria, the developer is required to conduct their own testing and submit a form to their certification body to disclose pertinent information. Developers should retain evidence of the tests and their results in the event that an ACB is required to conduct surveillance of one of the self-declared criteria.

Changes to Randomized Surveillance Requirements

On September 21, 2017 ONC announced they are relaxing the requirements for randomized surveillance conducted by ONC-ACBs. Prior to this change ONC-ACBs were required to conduct randomized surveillance on 2% of all certified products. ONC-ACBs are expected to continue good faith execution of any active and ongoing randomized surveillance to ensure product compliance with the Program. ONC-ACBs will also be expected to perform reactive in-the-field surveillance as part of complaints investigations as well as other reactive surveillance outlined in the CY 2017 Surveillance Plan.

 

2015 Edition Certification Testing Webinar Series

Experts from ICSA Labs, an ONC-Authorized Certification Body and Accredited Test Lab, will provide education on the certification testing requirements for the new 2015 Edition criteria.

Through attending these webinars, you will gain a better understanding of the following:

  • Gap-eligible criteria
  • Criteria updates and revisions
  • Certification testing requirements
  • Attestation documentation guidelines
  • Certification disclosure and transparency mandates

 

2/11 @ 2 pm ET  

Clinical and Security Criteria
RECORDING

Criteria 170.315(a)(1)-(15) and (d)(1)-(11)

2/25 @ 2 pm ET

Care Coordination, CQMs, and Patient Engagement Criteria
RECORDING

Criteria 170.315(b)(1)-(9), (c)(1)-(4), and (e)(1)-(3)

3/10 @ 2 pm ET

Public Health, Automated Measures, CCDA Performance, and Direct Criteria
RECORDING

Criteria 170.315(f)(1)-(7), (g)(1)-(2), (g)(6), and (h)(1)-(2)

3/17 @ 2 pm ET

Certification Disclosure and Transparency Requirements
RECORDING

Mandatory product disclosures, attestation and required reporting to be discussed

3/24 @ 2 pm ET

System Design and Application Access Criteria
RECORDING

Criteria 170.315(g)(3)-(5) and (g)(7)-(9)

 

2015 Edition 

2015 Edition Prep Packet and Study Guide

ICSA Labs will be offering a packet of preparation and guidance materials to assist in preparing for 2015 Edition certification. Purchasing the prep packet provides immediate access to the ICSA Labs custom test script, all guidance materials, and sample interoperability files. If you sign up for certification testing with ICSA Labs within 6 months of purchasing the prep packet, the cost of the prep packet will be applied to your certification testing engagement. To learn more, please contact ICSA Labs.

ONC Releases 2015 Edition Certification Final Test Method

ONC released the 2015 Edition Certification Final Test Method.  It can be accessed on the ONC Health IT Certification Program webpage. The 2015 Edition Test Method outlines the requirements for evaluating conformance of health IT Modules to the certification criteria defined in the ONC 2015 Edition Final Rule (45 CFR 170.315) published in the Federal Register on October 16, 2015.  Additionally, you will find a Certification Companion Guide (CCG) for each criterion which provides a comprehensive resource of clarifications most pertinent to health IT developers.

Meaningful Use - What’s Next?

The National Coordinator for Health IT, Karen DeSalvo published a post on healthit.gov’s blog in response to the most recent comments CMS made about Meaningful Use “going away” and “being replaced with something better.” ONC will continue to work with key stakeholders to ensure the certified technology program and new regulations:

· Focus on rewarding providers for outcomes
· Allow providers to customize HIT to fit their needs
· Level the technology playing field
· Prioritize interoperability

The program CMS has referenced as replacing meaningful use is MACRA, which also requires the use of Certified EHR Technology (CEHRT). By achieving certification, you are still assuring your clients’ ability to participate in federal incentive programs.

The 2015 Edition Final Rule

The 2015 Edition final rule, effective *January 14, 2016, establishes health IT certification criteria that support patient care, patient participation in care delivery, and electronic exchange of interoperable health information.  In addition, the final rule enhances the ONC Health IT Certification Program by including provisions for more rigorous testing of health IT exchange capabilities, establishing explicit requirements for in-the-field surveillance and transparency of health IT, and by making granular information about certified health IT publicly available through an open data certified health IT product list (CHPL).These steps will improve the reliability of certified health IT and provide more purchasing power to providers.

* (with the exception for Sections 170.523(m) and (n), which are effective on April 1, 2016)

Removal and Retirement of 2011 Edition

Per the 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange Final Rule, effective March 1,2015, the 2011 Edition EHR certification
criteria and related standards, terms and requirements have been removed from the Code of Federal Regulations (CFR 77 FR 54430, 54447).

The ONC Health IT Certification Program provides the following guidance:

  • ONC and NIST will archive the 2011 Edition Test Method (test procedures, tools and data).The CHPL will maintain the 2011 Edition certified products in an active status until 01 July 2015 so that participants programs permitting the use of 2011 products, which also require a CMS EHR Certification ID, will be able to generate these IDs. Beginning in July, these products will only be present in the CHPL download data file and will be marked as “retired.”
  • NVLAP Accredited Testing Laboratories (ATLs) will no longer test products for conformance to the 2011 Edition certification criteria. The 2011 Edition criteria should be removed from the ATL’s scheme/scope of testing.
  • ONC-Authorized Certification Bodies (ACBs) shall begin working with their clients to “retire” the 2011 Edition certifications they have granted and thus ceasing certification body responsibilities, such as surveillance. They should strongly encourage these developers to communicate this action to their clients with 2011 Edition certified products. The 2011 Edition criteria should be removed from the ACB’s scheme/scope of certification.

More information - FAQ 48 2011 Edition Retired

1/11/2015 – 2014 Edition Release 2 Test Methods

In September 2014, ONC published the 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange (or 2014 Edition Release 2) to the Federal Register. This final rule introduces regulatory flexibilities and general improvements for certification to the 2014 Edition EHR certification criteria (2014 Edition).  

The 2014 Edition, Release 2 test methods include some minor updates to existing criteria, as well as introducing additional new optional certification criteria such as:

  • splitting 170.314(a)(1) the “computerized provider order entry” (CPOE) criterion into three certification criteria 170.314(a)(18-20) based on capabilities (medications, laboratory, and diagnostic imaging;
  • shifting “incorporation” requirements to the 170.314(b)(9) “clinical information reconciliation and incorporation” (CIRI) criterion;
  • an ambulatory-domain only test procedure 170.314(f)(7) “transmission to public health agencies – syndromic surveillance” which evaluates the capability of EHR technology to electronically create syndrome-based public health surveillance information for electronic submission (using any method or standard). Included within this optional test procedure is an optional test to evaluate the capability of an ambulatory EHR technology to electronically create syndrome-based public health surveillance information containing specific data elements;
  • three new optional criteria intended to decouple content and transport capabilities from the Transitions of Care (ToC) certification criteria and the View, Download, Transmit (VDT) certification criterion.
    • The first transmission criterion 170.314(h)(1) "Transmit - Applicability Statement for Secure Health" mirrors the capability expressed at 170.314(b)(1)(i)(A) and 170.314(b)(2)(ii)(A);
    • the second transmission criterion 170.314(h)(2) "Transmit - Applicability Statement for Secure Health Transport and XDR/XDM for Direct Messaging" is based on the standard expressed at 170.314(b)(1)(i)(B) and 170.314(b)(2)(ii)(B); and
    • the third optional transmission criterion at 170.314(h)(3) "Transmit - SOAP Transport and Security Specification and XDR/XDM for Direct Messaging" will enable health information to be electronically transmitted in accordance with the standard specified in 170.314(b)(1)(i)(C) and 170.314(b)(2)(ii)(C).

The 2014 Edition, Release 2 test methods also include updates to existing criteria to incorporate the new optional 2014 Edition, Release 2 criteria such as:

  • 170.314(g)(1) Automated numerator recording and 170.314(g)(2) Automated measure calculation
  • 170.314(g)(3) Safety enhanced design

The complete 2014 Edition Test Method, including all of the updated Release 2 criteria (marked with “*”) can be found here.

 

 

Recorded Webinars

Jump Start Strategies for 2014 Edition Certification
In January 2013, the ONC launced the permanent Health IT Certification Program and released its 2014 Edition EHR Certification Criteria. These criteria set a higher bar for EHR software in new functional areas, and most organizations now face long development cycles as they prepare products for testing. This 30 minute webinar offers ideas and cost effective strategies your organization can adopt as you pursue 2014 Edition Certification.  View a recording of the webinar.

2014 Edition – Interoperability Standards and Updates
Join experts from ICSA Labs as they review the new and updated Interoperability standards, specifications and requirements published in the Final Rule for 2014 Edition Meaningful Use Certification Standards and Criteria. Standards and specifications discussed in the overview will include but are not limited to patient summaries and transitions of care documents (CCDA), transport requirements (DIRECT), and quality reporting (QRDA). View a recording of this webinar

2014 Edition – Privacy and Security Updates
With more than a decade of experience in evaluating information security products, our featured presenter, Kevin Brown, has extensive knowledge of various security and networking technologies.  His experience with real-world installations provides a valuable perspective on the challenges that EHR developers may face with the 2014 Edition Security and Privacy provisions.  Join ICSA Labs for an informative session exploring the nuances of these criteria.  View a recording of this webinar.

2014 Edition – Program and Clinical Criteria Updates
After much anticipation, the Final Rule governing the Stage 2 Standards and Certification Criteria has been released.  ICSA Labs would like to invite you to attend a free 60-minute webinar discussing general programmatic changes in the Permanent Certification Program and to take a deeper dive into the clinical criteria.  Our experts will provide an overview of these items and host a Q&A session afterwards.  This will be the first in a series of webinars hosted to take an in-depth look into the final rule.  View a recording of this webinar.

 

Other News

February 27, 2015 - HIMSS Blog: The Value of Interoperability Testing and Certification by Amit Trivedi

September 16, 2014 - Amit Trivedi quote in EHReporter - Raising Awareness to Improve Quality and Efficiency of Healthcare by Scott Rupp

May 13, 2014 - Government Health IT - Fear and loathing: the gray areas of meaningful use Stage 2 by Diana Manos

March 1, 2014 - Interoperability experts see a birght future including LTC by John Andrews

September 16-20, 2013 - ICSA participates in the 8th Annual National Health IT Week 

September 16, 2013 - Amit Trivedi quote in EHReporter - What is the Value of Health IT? by Scott Rupp

March 25, 2013 - HIMSS 2013 conference goer discuss interoperability in healthcare - Michelle Knighton quoted, by Ed Burns, TechTarget

January 28, 2013 - ICSA Labs set to certify EHR for Stage 2 Meaningful Use with Michelle Knighton by Kyle Murphy, PHD, EHRIntelligence.com